Addition of microRNA Blood Test to Lung Cancer Screening Low Dose CT

Description

To demonstrate that the specificity of the Hummingbird microRNA profile for the diagnosis of lung cancer in a cohort of patients who meet current eligibility criteria for lung cancer screening in the U.S. is superior to the specificity of LDCT.

Study Start Date

November, 01 2017

Estimated Completion Date

October 2018

Interventions

No interventions cited

Study ID

Hummingbird Diagnostics -- HMBDx USA-0001

Status

Recruiting

Trial ID

NCT03452514

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

400

Sponsor

Hummingbird Diagnostics

Inclusion Criteria

    1. Subject is undergoing LDCT screening for lung cancer. 2. Subject is 55 to 80 years of age. 3. Subject has a minimum 30 pack-year smoking history. 4. Subject has not quit smoking more than 15 years ago. 5. Subject is without symptoms attributable to lung cancer. 6. Subject is able and willing to provide informed consent.

Exclusion Criteria

    1. Subject has a history of lung, gastrointestinal, hematological, breast, thyroid, or genitourinary cancers within the past ten years. 2. Subject is known to be infected with HIV, HBV, HCV, or tuberculosis or any other Biosafety Level 3 (BSL III) pathogen infections.

Gender

All

Ages

55 Years to 80 Years

Accepts Healthy Volunteers

Not Listed

Study Locations and Contact Information (3)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Francine Jaconson MD 617-732-6285 fjacobson@bwh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Amita Sharma MD 617-724-4254 asharma2@mgh.harvard.edu
Lahey Hospital Medical Center - Burlington, Massachusetts 11.0 miles Kimberly RiegerChrist PhD 781-744-2969 kimberly.r.christ@lahey.org

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